Any time SAE occurs, regardless of the relationship with the study product, proper therapeutic measure should be loading on immediately. At the meantime, a case report including SAE specific report table should be sent to the main researcher, register and supervisor by telephone or email within 24 hours. The report to related administration within prescriptive time window should be also carried out in order to assist the inquiry held by the competent department and take proper strategy to redress the protocol and ensure prevention measure.